Heart FailureNCT04383080
The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
A study testing Acupuncture and Low-level laser therapy in people with Heart Failure and Acupuncture, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
Trial summary
The advantages of laser acupuncture are a non-invasive, painless, low risk of infection and high safety. Laser acupuncture as a treatment tool has the following advantages1.Painless, 2. Non-invasive treatment, the subject is highly accepted, the risk of infection and needle stick is low, 3. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Acupuncture
- What is being tested?
- Acupuncture and Low-level laser therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 17 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 20 years of age, with written informed consent.
- NYHA:stage II-III.
- All patients had LVEF <40% caused by dilated or ischemic cardiomyopathy.
- Acute HF patient presenting with dyspnea related to cardiogenic pulmonary edema.
- All patients had sinus rhythm, were stable and compensated with individually optimized standard heart failure medication as well as oral anticoagulants for at least 3 months before (including prophylactic defibrillator placement).
- Systolic blood pressure > 95 mmHg at admission.
- B-type natriuretic peptide (BNP) > 150 pg/mL or NT-pro BNP > 600 pg/mL.
Who cannot join
- Age under 20.
- Major cardiovascular events and treatments occurred four weeks before hospitalization.
- Major cardiovascular surgery or treatment will be performed in the next 6 months.
- Pregnant or expected to pregnancy within a year.
- Require a heart transplant in 6 months.
- Uncontrolled atrial or ventricular dysrhythmias.
- Uncompensated congestive heart failure.
- Heart failure due to congenital heart disease or obstructive myocardial disease
Trial locations and contacts
1 site in 1 country.
About this study
The advantages of laser acupuncture are a non-invasive, painless, low risk of infection and high safety. Laser acupuncture as a treatment tool has the following advantages1.Painless, 2. Non-invasive treatment, the subject is highly accepted, the risk of infection and needle stick is low, 3. Very few side effects such as fainting, bleeding, 4. The therapeutic dose is easy to operate, and the instrument output frequency, power and time can be controlled. Through the clinical physiological function test plus the verification and analysis of the quantitative test values, it will be more able to define the new role of laser acupuncture treatment in patients with heart failure from the perspective of Chinese medicine.
Read the detailed description
From the perspective of ancient books, the discussion of heart failure in the etiology and pathogenesis of traditional Chinese medicine was first seen in the "Shu Wen". It is clearly pointed out that "heart qi" is the basic pathogenesis of heart failure. The "qi" and "blood" of Chinese medicine are closely related. The blood line is driven by the gas, the blood is bloody, and the qi deficiency is unable to push the blood to blood. If the qi deficiency, it would lead to blood stasis; There were studies have indicated that traditional acupuncture treatment can increase exercise tolerance and adjust autonomic nerve activity in patients with chronic heart failure, and can reduce their readmission rate and mortality rate in patients with acute heart failure. Studies using laser acupuncture to treat patients with heart failure have also found that they can increase the subject's six-minute walking distance.
- Conditions
- Heart Failure, Acupuncture
- Being tested
- Acupuncture, Low-level laser therapy
- Keywords
- Low-level Laser, Acupuncture therapy, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
acupuncture at specific acupuncture points
Low-level laser therapyDevice
low level laser emission on specific acupuncture points
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy | Experimental | Low-level laser irradiation on specific acupuncture points Receives: Device: Low-level laser therapy |
| Acupuncture therapy | Active comparator | Dry needle inserting specific acupuncture points Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
N- terminal pro-brain natriuretic peptide, NT-proBNP
The change of NT-pro BNP from the date of admission to the end of trial
Measured: At the 12th week and 24th week
Secondary outcomes (1)
High sensitivity C-Reactive Protein, hs-CRP Hs-CRP
The change of NT-pro BNP from the date of admission to the end of trial
Measured: At the 12th week and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih Meng Chu, Bachelor, Principal investigator, National Yang Ming Chiao Tung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383080
- Sponsor's protocol ID
- NYMUH IRB No.2019b007
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT04383080
- Acronym / sponsor ID
- NYMUH IRB No.2019b007
- Conditions
- Heart Failure, Acupuncture
- Keywords
- Low-level Laser, Acupuncture therapy, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The advantages of laser acupuncture are a non-invasive, painless, low risk of infection and high safety. Laser acupuncture as a treatment tool has the following advantages1.Painless, 2. Non-invasive treatment, the subject is highly accepted, the risk of infection and needle stick is low, 3. Very few side effects such as fainting, bleeding, 4. The therapeutic dose is easy to operate, and the instrument output frequency, power and time can be controlled. Through the clinical physiological function test plus the verification and analysis of the quantitative test values, it will be more able to define the new role of laser acupuncture treatment in patients with heart failure from the perspective of Chinese medicine.
Detailed description
From the perspective of ancient books, the discussion of heart failure in the etiology and pathogenesis of traditional Chinese medicine was first seen in the "Shu Wen". It is clearly pointed out that "heart qi" is the basic pathogenesis of heart failure. The "qi" and "blood" of Chinese medicine are closely related. The blood line is driven by the gas, the blood is bloody, and the qi deficiency is unable to push the blood to blood. If the qi deficiency, it would lead to blood stasis; There were studies have indicated that traditional acupuncture treatment can increase exercise tolerance and adjust autonomic nerve activity in patients with chronic heart failure, and can reduce their readmission rate and mortality rate in patients with acute heart failure. Studies using laser acupuncture to treat patients with heart failure have also found that they can increase the subject's six-minute walking distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy | Experimental | Device: Low-level laser therapyLow-level laser irradiation on specific acupuncture points |
| Acupuncture therapy | Active comparator | Procedure: AcupunctureDry needle inserting specific acupuncture points |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 20 years of age, with written informed consent.
- NYHA:stage II-III.
- All patients had LVEF <40% caused by dilated or ischemic cardiomyopathy.
- Acute HF patient presenting with dyspnea related to cardiogenic pulmonary edema.
- All patients had sinus rhythm, were stable and compensated with individually optimized standard heart failure medication as well as oral anticoagulants for at least 3 months before (including prophylactic defibrillator placement).
Key exclusion criteria (8 listed)
- Age under 20.
- Major cardiovascular events and treatments occurred four weeks before hospitalization.
- Major cardiovascular surgery or treatment will be performed in the next 6 months.
- Pregnant or expected to pregnancy within a year.
- Require a heart transplant in 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupunctureacupuncture at specific acupuncture points | Procedure or surgery | Acupuncture therapy |
| Low-level laser therapylow level laser emission on specific acupuncture points | Device | Low-level laser therapy |
Primary outcome
N- terminal pro-brain natriuretic peptide, NT-proBNP
Time frame: At the 12th week and 24th week
The change of NT-pro BNP from the date of admission to the end of trial
1 secondary outcome
High sensitivity C-Reactive Protein, hs-CRP Hs-CRP
Time frame: At the 12th week and 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih Meng Chu, Bachelor principal investigator
National Yang Ming Chiao Tung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Low-level laser therapy in people with Heart Failure and Acupuncture, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N- terminal pro-brain natriuretic peptide, NT-proBNP (time frame: At the 12th week and 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.